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NCT01784562 Clinical Trial

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Hypertension, Pulmonary Clinical Trial

— EAS  

Official title:
An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01784562
Other study ID # 16097
Secondary ID 2012-002104-40
Status No longer available
Phase N/A
First received February 4, 2013
Last updated January 5, 2016

Study information
Verified date January 2016
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Health and Medicines AuthorityFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyJapan: Pharmaceuticals and Medical Devices AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Russia: Ministry of Health of the Russian FederationSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: SwissmedicTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationPortugal: INFARMED - National Authority of Medicines and Health Products
Study type Expanded Access

Clinical Trial Summary

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery

Exclusion Criteria:

- All types of pulmonary hypertension other than Dana Point Classification Group 4

- Operable patients listed for PEA (Pulmonary Endarterectomy)

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Adempas (Riociguat, BAY63-2521)
Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Italy,  Japan,  Mexico,  Netherlands,  Portugal,  Russian Federation,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

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